Job Description Summary

As directed by the QC Operation Supervisor, the Biochemist: Responsible for conducting quality analysis of bulk, in-process and finished goods under limited or no supervision following standard operating procedures. The Biochemist should demonstrate proficiency in applicable QC techniques, operation of relevant equipment and software packages associated with testing, data analysis, interpretation and reporting. QC Biochemist is able to perform troubleshooting, investigations, provide and follow corrective/preventive actions for failures and non-conformances.

Job Description

Primary Responsibilities and Duties

QC Test:

• Perform all assigned QC tests following analytical methods and procedures (qualitative and quantitative analysis of raw materials and bulk, in-process or finished goods) following analytical methods and procedures (such as Flow Cytometry or ELISA, WB (Western Blot) etc.) for products. This may require working with human blood, human or mammalian cell culture and/or animals and animal tissues.
• Assures bulks and/or finished products conform to established specifications.
• Reviews data on all QC testing as assigned. Performs investigation for atypical or Out of Specification (OOS) results and makes recommendations as appropriate.
• Provides technical guidance to resolve issues and follow-up on actions.
• Supports complaint investigations and report results.
• Performs material transactions in SAP system.
• Attending shift start up meetings and providing appropriate status follow-up.

• Ensures that cleaning, maintenance and calibration of QC equipment take place according to schedule.
• Ensures the required docs/records are available.

• Assists in the development and evaluation of new procedures and techniques and analyzes existing methods to suggest improvements. Performs Engineering Change Orders (ECO's) as needed. Assists the Supervisor in the preparation / review policies/procedures
• Provide recommendations to continuously improve product/process quality and enhance productivity, reduce cost, and increase production capability.

• Participates in assigned cross-training or off-site training as required. When experienced, helps new biochemists in area-specific trainings.
• Maintains working knowledge of current industry and international standards. Keeps abreast of the US and non-US regulations affecting own area of supervision/management and complies with those regulations. May propose changes to BD practices and procedures to support compliance requirements. Communicates the need for compliance to member of own functional area. Brings regulatory compliance questions/issues to the attention of the next level of management.
• Assures finished products conform to internal and government standards and satisfies ISO regulations.
• Promotes a safe work environment. Keeps abreast of the basic requirements for safety compliance in own area of work and complies with those requirements. Thoroughly understands lab safety and hazardous waste management. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental, Health & Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor and Safety Officer(s) of all observed hazardous conditions or unsafe work practices.
• May perform other related duties and assignments as required

• Bachelor or Master of Science degree in biology, biochemistry, chemistry, or other related degree
• 0-1 year of relevant laboratory experience in the pharma/biotech/academic research
• Knowledge of immunoassays related to cell biology applications: Cells immunophenotyping, ELISA and/or Western Blots
• English communication capabilities - mainly written
• Fluent Hungarian - written & spoken
• Motivation and proactive thinking
• Detail-oriented with strong written and verbal communication skills
• Contributing effectively to the accomplishment of team and work centers goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work
• Experience with pipetting (single- and multi-channel) in a small volume scale
• Experienced with Microsoft Applications: Excel, Word, PowerPoint
• Aware of general laboratory safety, biosafety procedures and standards
• Good time management, and ability to work independently
• Must have the ability to multi-task in a fast-paced environment